Robert Chairman and - warren.senate.gov

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Transcript of Robert Chairman and - warren.senate.gov

RobertA.BradwayChairmanandChiefExecutiveOfficer

AmgenOneAmgenCenterDrive28‐1‐EThousandOaks,CA91320‐1799805.447.1000DirectDial:805.447.8265E‐mail:[email protected]

June8,2018 

DearSenatorWarrenandSenatorSmith,IamwritinginresponsetoyourletterdatedMay30,2018regardingtherecentannouncementsbytheTrumpAdministrationondrugprices.Asyouknow,AmgenisaU.S.basedcompanythatemploysapproximately20,000employeesworldwidewithover500employeesbasedinMassachusettswhoarefocusedonresearchanddevelopment.Ourcompanyisfirstandforemostfocusedonpatienthealthandaddressingunmetmedicalneeds.Weareaccordinglyintentuponadvancingtheunderstandingofhumanbiologytoimprovepeople’slivesdramatically.Weshareyourconcernsthataffordabilitycanserveasabarriertopatientaccessandconsequentlysupportpoliciesthatseektoalignpricingtovaluetoreducecosts.Webelieveourpricingisconsistentwiththevaluedeliveredtopatients,providersandsociety,andwecontinuetoinvestheavilyinresearchanddevelopmentofnewmedicinesandtreatmentsforgrievousdiseases.Wehavelongrecognizedthehealthcaredeliveryandpaymentlandscapeischangingandthereforehavebeenforward‐lookingindevelopingvalue‐basedagreementswithpayers,providersandotherhealthcareorganizations.Byengaginginvalue‐basedprogramswithentitiesacrossthehealthcaresystem,Amgenhopestodevelopmutuallybeneficialopportunitiestoreducecosts,improvecareandenhancepatientexperiences.ThisreflectsAmgen’sbeliefthatmanagingdiseasethroughinnovativemedicineiskeytocontaininghealthcarecostsandimprovingpopulationhealth.WeareactivelyreviewingthePresident’sBlueprintandRequestforInformationtoLowerDrugPricesandReduceOut‐of‐PocketCostsandareengagedwithmanystakeholdersonthesecomplexandimportantissues.Ourfocusisonencouragingmarket‐based,patient‐centricsolutionsthatimprovecoverageandaccesstohelpmakemedicinesmoreaffordabletopatients.Withregardtopotentialpolicychanges,wetypicallyattempttodeterminetheirimpactuponourcompanyandourpatients,butthoseanalysesaremaintainedascompanyconfidentialcommercialinformation.AmgenstandsreadytocontinuetoworkwithCongressandtheAdministrationtofostermedicaladvancementsandpromotepatientaccesstovitaltreatments.

Sincerely,

RobertA.Bradway

DONALD BOHN 1350 I STREET, NW Vice President, Global Government Affairs Washington, DC 20005 Telephone: (202) 589-1000

June 8, 2018

The Honorable Elizabeth Warren

United States Senate

317 Hart Senate Building

Washington, D.C. 20510

Dear Senator Warren,

Thank you for your letter. We appreciate the opportunity to outline our commitment to transparency and

our responsible approach to pricing for our medicines.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities

and forward progress. Today, as the world’s largest and most broadly-based health care company, we are

committed to using our reach and size for good. We strive to improve access and affordability, create

healthier communities and put a healthy mind, body and environment within reach of everyone,

everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of

health for humanity.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we understand the need for greater

transparency around healthcare costs. That’s why we provide information about how we price our

medicines and invest our resources in an annual Janssen U.S. Transparency Report. As we highlight in

our second annual report released earlier this year, in 2017 the net price of our medicines in the U.S.

decreased while we increased our investment in discovering and developing transformational medicines

for patients facing some of the world’s most challenging diseases.

Some of the key disclosures that demonstrate our commitment to responsible business practices include:

• Our Investments: We are passionate about our work to deliver transformational medicines that can

change the trajectory of health for humanity. We focus our research and development (R&D)

investments on serious unmet medical need where we can make an enduring, meaningful impact. We

invest significantly in R&D—a total of $7.9 billion in 2017, which is 88 percent more than what

we spent on selling and marketing.

• Value: Our Janssen Value Assessment Principles help us define and measure the value of our

medicines to patients and society. In addition, we generate clinical information about how our

medicines affect people in their everyday lives so we can better understand the value our medicines

bring to patients and the health care system. Value assessments contribute to important conversations

about health system costs and the respective value of health care interventions, including medicines.

• Pricing & Patient Access: We maintain a responsible approach to pricing our medicines. And we

negotiate and partner with private and public payers and health care systems to support availability of

our products. As in past years, we limited our annual aggregate list price increase to single-digit

percentages. And last year, we provided discounts and rebates to payers and providers that

outweighed increase in list price, resulting in negative average aggregate net price.

• Resources for Patients: Patients should have access to affordable medicines. We aim to help patients

obtain appropriate access to medicines in a variety of ways. Through our Janssen CarePath and

JANSSEN CONNECT® programs, we provide options to help patients start on, and stay on, the

Janssen medicine prescribed by their health care provider. We also support charitable organizations

and foundations that help patients get the medicines they need. While we recognize these programs

are not a long-term solution for all patients, they are one way we strive to meet the needs of the

patients we serve and the health care professionals who care for them.

Please visit http://janssen.com/2017ustransparencyreport to view more information.

In addition to the report, we can confirm that we have not taken list price action since May 11, 2018.

We are committed to ensuring all Americans have access to the benefits of innovative medicines. As

such, we are currently evaluating the proposals in the “HHS Blueprint to Lower Drug Prices and Reduce

Out-of-Pocket Costs” to understand how they might affect access for patients today and innovation for

patients tomorrow. Given that this is the beginning of a lengthy process, it’s difficult to estimate the

impact to the business at this time.

We are willing to explore additional options that would give patients meaningful and relevant information

related to pricing in consumer-facing materials. It’s important to remember that patient out-of-pocket

costs can vary significantly based on an individual’s health coverage. We are also supportive of exploring

a broad range of policy solutions that would reduce out-of-pocket costs of medicines for patients.

As we move forward, we will continue to work with others who share our commitment to access and

transparency to develop a more results-based health care system that delivers what we all want: greater

access to care, at manageable cost, and most importantly, better health for all.

Thank you again for the opportunity to provide this information.

Sincerely,

Donald Bohn

www.pfizer.com

Robert W. Jones Pfizer Inc Senior Vice President 1275 Pennsylvania Ave, NW, Suite 600 U.S. Government Relations Washington, DC 20004 Tel 202 624-7518 [email protected]

The Honorable Elizabeth Warren The Honorable Tina Smith United States Senate United States Senate Washington, DC 20510 Washington, DC 20510 June 8, 2018 Dear Senators Warren and Smith,

Thank you for your recent letter to Pfizer Chairman and CEO Ian Read regarding medicine pricing and the Administration’s recent proposals to address affordability and access to medicines. I am responding on behalf of Pfizer.

Pfizer is committed to pricing our medicines in a way that reflects the benefit they bring to patients and society; ensuring patients have reasonable access and enabling us to continue to invest in new medicines. We may consider several factors when setting a price for a product. This may include the product’s likely impact on patients and their disease, the role of generic developments, affordability, investments to maintain quality, safety, reliability; and our ability to continue to innovate to bring new, life-changing medicines and vaccines to patients. We also consult physicians, payers and patient groups, as appropriate.

Given our concerns with affordability, we are considering the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs very carefully. We are in the process of reviewing and assessing the wide-ranging proposals and questions included in the Request for Information (RFI) that accompanied the Blueprint. The RFI poses more than a hundred questions, and touches upon numerous federal and state programs which are significant to our business, and addresses critical aspects of our commercial operations. We would be pleased to share with you a copy of our response after we have submitted it to the Department of Health and Human Services.

We are particularly encouraged to see that the Blueprint furthers momentum around rebate pass-through, which we believe has the potential to meaningfully improve affordability at the pharmacy counter for the many patients for whom pharmaceutical manufacturers provide substantial rebates. More needs to be done to ensure beneficiaries directly benefit from significant price negotiations taking place in the Part D market. Seniors share the costs; they should also share the savings.

While health plans might use some portion of these rebates to lower premiums, that practice dilutes the benefits of the rebates and diverts them from the patients who need them most. Analysis by the actuarial firm Milliman finds that passing through 50% of manufacturer rebates and 100% of pharmacy discounts would reduce beneficiaries’ average total out-of-pocket spending, and could save beneficiaries between $4B and $28B over 10 years. Milliman also estimates that over time, beneficiary premiums could decline once anticipated changes in plan-manufacturer contracting strategies occur. (Milliman, 2018)

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Again, thank you for your letter. We look forward to working with Congress, the Administration, and other key stakeholders to help ensure that all Americans have access to affordable medicines.

Sincerely,

Robert W. Jones Senior Vice President, US Government Relations

SANOFI US, 55 Corporate Drive, Bridgewater, NJ 08807

June 8, 2018 The Honorable Elizabeth Warren 317 Hart Senate Office Building Washington, DC 20510 The Honorable Tina Smith 309 Hart Senate Office Building Washington, DC 20510 Dear Senator Warren and Senator Smith:

I am writing in response to your inquiry, dated May 30, 2018, addressed to Dr. Olivier Brandicourt, concerning the Administration’s recent actions regarding prescription drug costs for Americans.

Thank you for the opportunity to share our perspective about prescription drug pricing and patient access and affordability to the medicines they need. As a global biopharmaceutical leader, we recognize that Sanofi has an important role to play to ensure affordable and sustainable access to the prescription medicines we discover, develop and manufacture and we have taken several steps to try to alleviate the challenges facing patients. Sanofi’s Commitment to Responsible Pricing Last year, Sanofi announced new pricing principles. These principles express our intent to limit list price increases in the U.S. at or below an independent standard measure of health care inflation (the national health expenditures (NHE) growth projection as determined by the Department of Health and Human Services), which was estimated to be 5.4 percent in 2017 and 5.3 percent in 2018. We also pledged to provide greater transparency around how we set our prices at launch based on clinical, economic and social value, as well as affordability. This policy applies to all of our medicines. We have also committed to greater transparency to help stakeholders better understand the interaction of list and net prices; in 2016, the average list price for all of our medicines increased by 4 percent while our total net price declined by 2.1 percent. In 2017, Sanofi increased the list price of 29 of our 85 prescription medicines, resulting in an average list price increase last year for all of our medicines of 1.6% and a net price decline of 8.4%. While list prices often receive the most attention, they reflect the initial prices set for our medicines and are not the prices typically paid by the insurers, employers, or pharmacy benefit managers who purchase our medicines on behalf of patients and their respective health plans. We negotiate significant discounts and rebates with these payers, which leads to lower prices in exchange for greater access for patients. It is our belief that the declining net prices for our medicines should result in improved access and lower prescription drug costs for patients. Unfortunately, it does not appear that payers consistently pass

SANOFI US, 55 Corporate Drive, Bridgewater, NJ 08807

through the growing savings from increased negotiated rebates and discounts to patients by lowering costs at the pharmacy counter. Additionally, earlier this year, we announced the launch of the Insulins VALyou Savings Program, a new plan that aims to lower out-of-pocket costs for people who manage their diabetes with Lantus (insulin glargine 100 Units/mL) and Admelog (insulin lispro injection). The intent of the Insulins VALyou Savings Program is to help patients currently paying full retail price for Lantus and/or Admelog. This includes certain uninsured patients who don’t qualify for traditional patient assistance programs as well as some commercially insured patients with a high deductible that has not been reached on their plan. The program is available at all U.S. pharmacies and, for some people, the program could offer significant savings – up to $5,500 per year – compared to the out-of-pocket cost of other long-acting or fast-acting insulins. Sanofi’s Perspective on the Administration’s Blueprint and RFI We are currently reviewing the Administration’s “blueprint” and the request for information (RFI). Though our analysis is ongoing, we believe there are a number of policies raised in the RFI which could ultimately help with patient access and affordability. For example, the Administration has indicated they support increasing competition by preventing companies from attempting to block generic entry through misuse of the Risk Evaluation and Mitigation System (REMS) process. We have a longstanding policy to provide samples to generic and biosimilar manufacturers and we support the Administration’s desire to address this issue. Additionally, Sanofi supports efforts to reduce out-of-pocket spending for patients at the point of sale. Despite increasing rebates, out-of-pocket costs for many patients have continued to grow. In some cases, the growth has been driven by changes to insurance benefit designs, including a rise in the prevalence of high-deductible health plans and coinsurance requirements. These benefit designs continue to shift costs to patients despite market competition driving costs down for both pharmacy benefit managers (PBMs) and payers in certain therapeutic areas. There are many other issues outlined in the RFI, many of which have the potential to improve the system for patients while we believe others may have unintended consequences that could result is less access for Medicare beneficiaries. Ultimately, how each of these issues are addressed – and how some interact with each other – will determine the benefit for consumers. However, Sanofi applauds the Administration’s willingness to substantively, thoroughly and openly explore a range of options to help patients instead of pursuing options, such as importation or repealing non-interference, that may be more politically expedient but repeated analysis suggests would provide little, if any, benefit for consumers.

SANOFI US, 55 Corporate Drive, Bridgewater, NJ 08807

Improving Access and Affordability Despite the meaningful steps we have taken, we also recognize that more needs to be done to improve access and affordability for people. Given the diversity of our health care system, there is likely not a single, one size fits all, approach. Instead, all stakeholders, including policy makers, manufacturers, payers and physicians, in partnership with patients, need to work together to find a range of solutions to address high out-of-pocket burdens and to provide dependable access to needed treatments. We look forward to continuing to work with you to ensure that people have access to affordable medicines. Should you have any additional questions or concerns, please do not hesitate to contact me. Sincerely,

Adam Gluck Senior Vice President, U.S. External Affairs